Resectable pancreatic adenocarcinoma with risk factors
Conditions
Brief summary
Overall Survival: Time a patient lives from the date of treatment initiation to exitus. The start date of treatment will be the date of surgery (in case of patients in the control arm) or the date of cycle 1 of chemotherapy (in case of patients in the experimental arm).
Detailed description
Invasive disease-free survival and event-free survival: The time a patient lives (or survives) without relapse of invasive disease after treatment (number of months until local or metastatic disease relapse). Whether the relapse is local or metastatic shall be specified., Number of cycles completed by patients., Monitoring of the appearance of new lesions., CA19,9 levels., Types of post-surgical events. Clavien-Dindo (C-D) classification and the 2016 update International Study Group of Pancreatic Fistula (ISGPF) classification. Delayed Gastric Emptying (DGE) and post-surgical bleeding classification ISGPF 2007., R0 resection rates., Number and nature of adverse events, Number and/or percentage of patients with intention to treat., QLQ-C30 quality of life questionnaire
Interventions
DRUGIRINOTECAN
DRUGFLUOROURACIL
DRUGCALCIUM FOLINATE
DRUGOXALIPLATIN
Sponsors
La Fundacion Para La Gestion De La Investigacion Biomedica De Cadiz
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Survival: Time a patient lives from the date of treatment initiation to exitus. The start date of treatment will be the date of surgery (in case of patients in the control arm) or the date of cycle 1 of chemotherapy (in case of patients in the experimental arm). | — |
Secondary
| Measure | Time frame |
|---|---|
| Invasive disease-free survival and event-free survival: The time a patient lives (or survives) without relapse of invasive disease after treatment (number of months until local or metastatic disease relapse). Whether the relapse is local or metastatic shall be specified., Number of cycles completed by patients., Monitoring of the appearance of new lesions., CA19,9 levels., Types of post-surgical events. Clavien-Dindo (C-D) classification and the 2016 update International Study Group of Pancreatic Fistula (ISGPF) classification. Delayed Gastric Emptying (DGE) and post-surgical bleeding classification ISGPF 2007., R0 resection rates., Number and nature of adverse events, Number and/or percentage of patients with intention to treat., QLQ-C30 quality of life questionnaire | — |
Countries
Spain
Outcome results
None listed